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NCT Number: NCT01503463

Remote Monitoring of Patients With CHF in Central Greece

The purpose of this study is to evaluate whether telemonitoring of patients with chronic heart failure produces a reduction in the combined end point of all cause mortality and number of hospitalisations, and whether it improves health related quality of life. In addition, the trials evaluate the economic and organisational impact of the telemonitoring service and examine its acceptability by patients and health professionals.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiology Department - Regional University Hospital of Larisa

Larissa, Thessaly, 41110, Greece

About this study

The purpose of this study is to the evaluate the use of a mobile and PSTN phone-based telehealth platform will be able to produce a reduction in the combined end point of all cause mortality, will have positive or negative impact in their generic and disease specific quality of life , or their specific activity compared with usual care. Following this; it is also hypothesized that this will also lead to a change in overall risk for CHF complications. In addition the patients' satisfaction using the telemedicine service will be studied. A Cost-Effective Analysis and Cost Utility Analysis will evaluate the tele-health service compared with the usual care from the health and social perspective.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 65 years.
  • Discharge from hospital after acute heart failure in the previous 3 months and FE < 40% or FE > 40% plus BNP > 400 (or plus NT-proBNP>1500) during hospitalization

Exclusion criteria

  • Comorbidities prevalent on CHF with life expectation < 12 months.
  • Inability to use the equipment and help at home not available.
  • Myocardial infarction or percutaneous coronary intervention in the last 3 months.
  • Coronary artery bypass, valve substitution or correction in the last 6 months or scheduled.
  • Being on waiting list for heart transplantation.
  • Being enrolled in other trial.

Treatment and study plan

Home telemonitoring of patients with CHF

Procedure

Patients in the intervention group receive a personal 1-lead or 12-lead ECG recorder, a blood pressure monitor, a digital weight scale and appropriate education regarding the use of these devices. ThA trained nurse visits the patients weekly during the first month, and monthly thereafter, to confirm the appropriate use of the devices and services, to monitor symptoms, adherence to pharmacological and non-pharmacological treatment, and to complete the case record forms when necessary.

If there is deterioration in the monitored vital signs, or if symptoms are reported, the allocated cardiologist is informed via the telehealth platform and has to decide whether the patient has to visit the hospital as in- or outpatient and whether the therapy has to be modified.

Primary outcomes

  1. Combined end point of all cause mortality

    Time frame: 12 months minimum

  2. Number of hospitalisations for heart failure

    Time frame: 12 months minimum

Secondary outcomes

  1. Cardiovascular and all-cause mortality

    Time frame: 12 months minimum

  2. Health related quality of life as measured by the SF-36 v2

    Time frame: 12 months minimum- at the entry point of the intervention and the end

  3. Patient's specific activity using Specific activity questionnaire (SAQ) and the Veterans specific activity questionnaire (VSAQ)

    Time frame: 12 months minimum- at the entry point of the intervention and the end.

  4. Disease Specific Quality of Life using the Minnesota Living with Heart Failure questionnaire (MLHF)

    Time frame: 12 months minimum- at the entry point of the intervention and the end.

  5. Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis)

    Time frame: 12 months minimum

  6. Patients' Acceptance-Satisfaction measured by the WSD Questionnaire

    Time frame: at 2nd and at 12th month

Sponsors and collaborators

Lead sponsor

Regional Health Authority of Sterea & Thessaly

Other Gov

Collaborators

  • Alexander Technological Educational Institute, Thessaloniki, Greece
  • Institute of Biomedical Research & Technology, Larissa, Greece
  • Institute of Communications and Computer Systems, Athens, Greece
  • Ministry for Health and Social Solidarity, Greece
  • Municipality of Trikala, Greece
  • University of Macedonia, Thessaloniki, Greece
  • University of Thessaly

Registry information

Official study title

Renewing Health RCT for the Evaluation of Remote Monitoring of Patients With Congestive Heart Failure (CHF) in Central Greece

Acronym: RHCluster7GR

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jan 4, 2012
Registry last updated
Mar 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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